System, method and apparatus for placing therapeutic devices in a heart

Abstract

The present invention relates to a system and method for positioning a sheath and guiderail catheter into the Coronary Sinus (CS) to introduce pacing therapy within a heart of a subject. The guiderail catheter can be customized into a shape compatible with the subject's anatomy and also provide for shapeability of the guiderail catheter. The method includes introducing the sheath into the heart of the subject, with the sheath positioned in the right atrium. The guiderail catheter is introduced into the heart of the subject through the distal end of the sheath and advanced past the distal end of the sheath into the right atrium of the heart to a position near the septum and further guiding the distal end of the guiderail catheter into the coronary sinus.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to and the benefit of the filing of U.S. Provisional Patent Application Ser. No. 61 / 309,285, entitled “WEST SYSTEM AND METHOD”, filed on Mar. 1, 2010, and the specification and claims thereof are incorporated herein by reference.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT[0002]Not Applicable.INCORPORATION BY REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC[0003]Not Applicable.COPYRIGHTED MATERIAL[0004]Not Applicable.INTRODUCTION[0005]Minimally invasive procedures have been implemented in a variety of medical settings, e.g., for vascular interventions, such as angioplasty, stenting, embolic protection, electrical heart stimulation, heart mapping and visualization, delivery of pacemakers, and the like. These procedures generally rely on accurately navigating and placing instruments within a patient's vasculature.[0006]During such procedures, a target vessel or structure may be accessed u...

AI Technical Summary

Benefits of technology

The present invention provides a device and method for efficiently placement of small, flexible medical devices, such as electrode leads, into the heart, particularly the coronary sinus. It allows the user to modify the catheter at the time of implant to a shape that conforms or adapts to the anatomy of a patient, which leads to cost and time savings and makes the overall risk of the procedure less by limiting repeated exchanges. The introducers as disclosed in the patent are fixed in their shape, not capable of having a user introduce an increased or decreased curve into the sheath, and do not have 1:1 torque or woven stiffening elements covered by a pliable biocompatible polymer coating.

Problems solved by technology

However precise positioning often remains elusive with current systems and apparatus for positioning.

Further, the guidewire alone is not desirable for guiding placement of sheaths in some locations within the body.

However, because of this flexibility, it is quite difficult to advance these devices through the patient's vasculature into the heart without the use of some temporary, removable stiffening element with the device.

However, there are several disadvantages to this procedure.

Once an opening is created, frequently by use of a hollow needle, a dilator is usually inserted into the vasculature, which gradually increases the size of the opening.

Gaining access to the ostium of the coronary sinus is often difficult and time consuming.

This may increase patient risk and overall procedure time and expense.

The anatomical structures located near the coronary sinus within the right atrium are not easily recognizable with fluoroscopic imaging, adding to this difficulty.

Current procedures available for introduction of devices such as pacemaker leads, implantable defibrillator leads, specialized catheters or devices used for cardioversion into the coronary sinus are frequently time consuming and difficult.

One limitation of fixed shape catheters and introducers as described in U.S. Pat. No. 6,277,107 and other commercially available catheters and sheaths is an inherent inability for uniform application throughout the highly varied patient anatomies.

The inherent disadvantage is the frequent need during implantation to open and use many sheaths as often times the first sheath or introducer chosen is too short or long or does not have the appropriate curvature for the particular anatomy.

These features of the sheath or introducer cannot be modified by a user.

Anatomic limitations inherent with the typical patient for whom these devices are implanted make a fixed curve sheath or catheter limited to only a single type of anatomic variant.

While several preshaped or biased introducers have been proposed, the shapes provided are still difficult to manipulate successfully and quickly into the coronary sinus.

It typically takes a considerable amount to time and physician skill to manipulate these fixed shape introducers successfully into the opening of the coronary sinus.

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